Intervening on Reproductive Health in Young BC Survivors

Institution: University of California, San Diego
Investigator(s): Irene  Su , M.D. -
Award Cycle: 2014 (Cycle 20) Grant #: 20OB-0144 Award: $968,782
Award Type: Translational Research Award
Research Priorities
Community Impact of Breast Cancer>Sociocultural, Behavioral, and Psychological Issues: the human side



Initial Award Abstract (2014)

Non-technical overview of the research topic and relevance to breast cancer: The study proposes to generate and test the efficacy of the Reproductive Health Survivorship Care Plan (SCP-R), a novel survivorship care tool to meet the reproductive health needs of young breast cancer survivors (YBCS). Ten percent of the 2.8 million breast cancer survivors in the U.S. were diagnosed with cancer when they were younger than 45 years old. Most young patients undergo chemotherapy and/or endocrine therapy, treatments that impair ovarian function and result in significant reproductive health late effects. These late effects include symptoms of estrogen deprivation such as hot flashes, fertility concerns, limited contraception options and sexual problems. Together they have a major, negative impact on quality of life. Despite substantial research, treatment guidelines and clinical expertise on these issues, most YBCS and their healthcare providers (HCPs) have limited guidance on how best to manage these reproductive health late effects. Consequently, YBCS’s informational and clinical care needs are not met by currently available resources. In 2006, the Institute of Medicine recommended development of survivorship care plans to improve patient knowledge about the effects of cancer and guide follow up care. However, these plans lack adequate guidance on reproductive health. Therefore, we propose to translate available knowledge on managing reproductive health issues in YBCS into a practical, accessible, evidence-based tool (the SCP-R) to address this deficit in survivorship care. The proposal responds to the CBCRP research priority on the community impact of breast cancer by focusing on delivery of reproductive healthcare to YBCS, a medically underserved population. The long-term goal is to incorporate the SCP-R into existing survivorship care plans for dissemination and sustainability.

The question(s) or central hypotheses of the research: The study will determine if the Reproductive Health Survivorship Care Plan tailored to individual survivor needs will improve estrogen deprivation symptoms, fertility concerns, contraceptive practices and sexual function in YBCS. In addition, healthcare providers who receive the tailored SCP-R will have improved preparedness on managing reproductive health issues in YBCS and more discussion of these issues with their patients, compared to HCPs who do not receive the SCP-R.

The general methodology: The goal of the project is to generate the web-based SCP-R and test its impact on YBCS and their HCPs. The study will focus on YBCS who were age 45 and younger at diagnosis and within five years of diagnosis because of the unique reproductive health needs in this population. As HCPs are a key source of cancer-related information and decisions, the SCP-R will also target providers. The research team is comprised of patient advocates and seasoned investigators in reproductive health, breast oncology, primary care, cancer survivorship, health behavior and clinical trials. This dedicated team will translate the large body of knowledge on estrogen deprivation symptoms, fertility concerns, contraception, sexual health from research, professional societies and clinical expertise into practical, evidence-based screening and management strategies for YBCS and HCPs. These strategies will be incorporated into the SCP-R. In the clinical trial, 157 YBCS will be randomized in equal numbers to receive the SCP-R and biweekly reproductive health prompts that are tailored to their reproductive needs (intervention group), or usual care (waitlist control group). Over six months of follow up, YBCS will be asked to track hot flashes daily and undergo periodic assessments of fertility concerns, contraceptive practices and sexual function. Each YBCS will be asked to identify a HCP who will receive the same information as their patient. Providers will be asked about their preparedness to manage reproductive health issues. HCP discussions of reproductive health issues with their patient will be determined. We will compare outcomes by intervention group.

Innovative elements of the project: The project will be the first to address a gap in research on translating knowledge on reproductive health into health services delivery to improve everyday outcomes in YBCS. While multiple general survivorship care plans have been developed and are widely available on the Internet, none have been tested to improve reproductive health outcomes. Among ongoing trials reported in large research and grant funding databases, none aim to improve reproductive health issues that figure so prominently in quality of life of young breast cancer survivors. The proposed SCP-R intervention is novel in its focus on reproductive health, design to impact multiple levels (YBCS and HCPs) and tailoring to individual need. These innovations will change the current approach to survivorship care planning by integrating specialty care outside of oncology, emphasizing the multi-disciplinary approach to caring for cancer survivors. The attributes will result in high likelihood of delivering an impactful survivorship tool to improve long-term reproductive health in young breast cancer survivors.




Progress Report 1 (2015)

Ten percent of the 2.8 million breast cancer survivors in the United States were diagnosed with cancer when they were younger than 45 years old. Most young patients undergo chemotherapy and/or endocrine therapy, treatments that impair ovarian function and result in significant reproductive health late effects. These late effects include symptoms of estrogen deprivation such as hot flashes, fertility concerns, limited contraception options and sexual problems. Together they have a major, negative impact on quality of life. Despite substantial research, treatment guidelines and clinical expertise on these issues, most young breast cancer survivors

(YBCS) and their healthcare providers (HCPs) have limited guidance on how best to manage these reproductive health late effects. To meet the informational and clinical care needs of YBCS, the goal of the project is to generate a web-based survivorship care plan on these reproductive late effects and test its impact on YBCS and their HCPs.

In the first year of the project, we have accomplished the first aim to develop a prototype for the tailored reproductive health survivorship care plan (SCP-R). We conducted systematic reviews of scientific studies and professional society guidelines on four reproductive health areas: hot flashes, fertility concerns, contraception and sexual problems. Findings of our systematic reviews were then converted into written materials for YBCS and HCPs. These written drafts of the SCP-R were reviewed and revised by our multi-disciplinary expert panel, which includes breast cancer advocates, researchers, and HCPs in reproductive health, primary care, breast oncology, and cancer survivorship. The SCP-R prototype was then ready for pilot testing.

The second aim of the study is to pilot test the SCP-R prototype with YBCS and HCPs through focus groups of YBCS and HCPs of young survivors to refine the intervention. We have conducted 4 of 5 focus groups and are initiating HCP interviews. These focus groups have been invaluable in assessing the survivorship care plan, website content, messages and structure in terms of ease of comprehension, credibility and persuasiveness. The focus group feedback has modified the SCP-R content and structure. The systematic reviews have generated two scientific manuscripts that are currently undergoing review. We have not encountered any significant barriers in undertaking this project. In the second year of the project, we will complete the HCP interviews and modification of the SCP-R, and we will begin the randomized controlled trial to test the efficacy of the SCP-R on improving estrogen deprivation symptoms, fertility concerns, contraception and sexual function.

Publications:
Informing hot flash treatment decisions for breast cancer survivors: a systematic review of randomized trials comparing active interventions




Progress Report 2 (2016)

Ten percent of the 2.8 million breast cancer survivors in the United States were diagnosed with cancer when they were younger than 45 years old. Most young patients undergo chemotherapy and/or endocrine therapy, treatments that impair ovarian function and result in significant reproductive health late effects. These late effects include symptoms of estrogen deprivation such as hot flashes, fertility concerns, limited contraception options and sexual problems. Together they have a major, negative impact on quality of life. Despite substantial research, treatment guidelines and clinical expertise on these issues, most young breast cancer survivors (YBCS) and their healthcare providers (HCPs) have limited guidance on how best to manage these reproductive health late effects. To meet the informational and clinical care needs of YBCS, the goal of the project is to generate a web-based survivorship care plan on these reproductive late effects and test its impact on YBCS and their HCPs.

In the first year of the project, we accomplished the first aim to develop a prototype for the tailored reproductive health survivorship care plan (SCP-R). We conducted systematic reviews of scientific studies and professional society guidelines on four reproductive health areas: hot flashes, fertility concerns, contraception and sexual problems. Findings of our systematic reviews were then converted into written materials for YBCS and HCPs. These written drafts of the SCP-R were reviewed and revised by our multi-disciplinary expert panel, which includes breast cancer advocates, researchers, and HCPs in reproductive health, primary care, breast oncology, and cancer survivorship. The SCP-R prototype was then ready for pilot testing.

In the second year of the project, we completed the second aim of the study by pilot-testing the SCP-R prototype with YBCS and HCPs. We conducted 5 focus groups with 37 YBCS and structured interviews with 9 HCPs. These activities have been invaluable in assessing the survivorship care plan, website content, messages and structure in terms of ease of comprehension, credibility and persuasiveness. In addition, based on YBCS feedback, we removed tailoring access to content, as overwhelmingly, our participants wished to access content on all 4 late effect areas (hot flashes, fertility concerns, contraception and sexual health).

Following refining the content of the SCP-R, we have developed the study web-site to support the clinical trial. In March, 2016, we have initiated recruitment for the randomized controlled trial to test the efficacy of the SCP-R on improving estrogen deprivation symptoms, fertility concerns, contraception and sexual function.




Conference Abstract (2016)

Intervening on Reproductive Health in Young Breast Cancer Survivors: Development of the Women’s Health Survivorship Care Plan

Sally A. Dominick PhD, MPH1, Claire Johns BS2, Jun J. Mao MD, MSCE3, Loki Natarajan PhD4, John Pierce PhD4, Jessica R. Gorman PhD, MPH5, Sarah Boles MD6, Diana T. Chingos MS, MFA7, Jennifer L. Ehren PhD, MS8, Michael L. Krychman MD9, H. Irene Su MD, MSCE1
1Department of Reproductive Medicine, University of California, San Diego
2School of Medicine, University of California, San Francisco
3Integrative Medicine Service, Memorial Sloan Kettering Cancer Center
4Department of Family Medicine & Public Health, University of California, San Diego
5College of Public Health and Human Sciences, Oregon State University
6Department of Medicine, University of California, San Diego
7Young Survival Coalition, Patient Advocate
8Susan G. Komen, Patient Advocate
9Southern California Center for Sexual Health and Survivorship Medicine

Background and goal: The goal of this research project is to develop and test the efficacy of the Women’s Health Survivorship Care Plan (SCP), a novel survivorship care tool to meet the reproductive health needs of young breast cancer survivors (YBCS) and their healthcare providers (HCPs). Ten percent of the 2.8 million breast cancer survivors in the U.S. were younger than 45 years old when they were diagnosed with cancer. Most of these YBCS will experience reproductive health late effects (hot flashes, fertility concerns, limited birth control options and sexual health problems). As well, YBCS are at higher risk of having a hereditary cancer syndrome. Taken together, these survivorship issues can have a negative impact on quality of life. To address these issues and improve quality of life, we have developed a web-based educational intervention targeting both YBCS and their HCPs.

Hypothesis: We will test the hypothesis that YBCS who receive the SCP will have improved hot flash symptoms, fertility concerns, birth control practices, and sexual function and an increased uptake of genetic risk assessment compared to YBCS who do not receive the SCP. Healthcare providers who receive the SCP will have improved knowledge and preparedness on managing these reproductive health survivorship issues in YBCS, compared to HCPs who do not receive the SCP.

Methods and approaches: To develop the SCP content for each of the 5 survivorship issues (hot flashes, fertility concerns, birth control, sexual health and cancer genetic risk), our research team conducted systematic literature reviews, reviewed professional society guidelines and incorporated clinical expertise into practical and evidence-based educational information geared towards YBCS and their HCPS. For each issue addressed in the SCP, the following content sections were created: 1) "Survivorship Care Plan" - take-home points and action steps outlining management strategies, 2) “What does evidence show?” - a summary of clinical research studies, 3) "What do clinical guidelines say?" - a summary of professional healthcare society guidelines, and 4) "Resources" - a curated list of helpful online resources. Next, focus groups with a total of 37 YBCS (each group had 4-8 YBCS) and structured interviews with 9 HCPs were conducted to review and gain feedback on the content sections for each issue. Based on the feedback and comments from this qualitative research, the SCP content was revised and formatted into a web-based educational intervention that will be tested in a randomized controlled trial starting March 2016.

Impact on breast cancer: The Women’s Health Survivorship Care Plan provides up-to-date, evidence-based information on managing hot flashes, fertility concerns, birth control practices, sexual health and cancer genetic risk geared towards YBCS and their HCPs. The impact of this intervention on YBCS and their HCPs will be the provision of an accessible, web-based SCP tool geared towards improving knowledge and providing management strategies for reproductive health survivorship issues after breast cancer.